From their meeting in November, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
November’s meeting saw five medicines recommended for approval including three new medicines, one orphan medicine and one biosimilar.
A marketing authorisation was recommended for Phesgo (pertuzumab / trastuzumab) for the treatment of early and metastatic breast cancer. The committee adopted positive opinions for Roclanda (latanoprost/netarsudil) for reduction in elevated intraocular pressure, Xofluza (baloxavir marboxil) for the treatment and post-exposure prophylaxis of uncomplicated influenza, and the biosimilar Onbevzi (bevacizumab) for the treatment of various cancers. CHMP also approved a marketing authorisation for Elzonris (tagraxofusp) following re-examination after a refusal in July 2020. After re-examination, the committee decided that it could be recommended under exceptional circumstances for a restricted indication.
Additionally, there were six recommendations for extensions of therapeutic indications including Kyprolis, Pradaxa, Tivicay, Trimbow, Xarelto and Xyrem.
Following re-examination of Gamifant (emapalumab), the committee confirmed their original position of a negative recommendation. Three applications for initial marketing authorisations were also withdrawn, for Puldysa (idebenone), Roctavian (valoctocogene roxaparvovec) and Tibsovo (ivosidenib).
The CHMP has aligned its recommendations for limiting nitrosamine impurities in sartan medicines with all other classes of medicines. The main change concerns the limits for nitrosamines, which previously applied to the active ingredients but will now apply instead to the finished products (e.g. tablets).
They also reported the outcome of a review on medicines containing uliprastal acetate. They recommended restricting use of these medicines due to cases of serious liver injury.
A detailed report of the meeting outcomes can be found here.